Letter

U.S. Senator Joe Manchin (D-W.Va.) and members of Congress sent a bipartisan letter to the Commissioner of the Food and Drug Administration today to urge immediate action on rescheduling drugs containing hydrocodone to help curb the prescription drug abuse epidemic, as recommended by the FDA's own advisory board.

We are writing to respectfully urge your agency to act without delay to reschedule hydrocodone combination drugs from Schedule III to Schedule II, as recommended by the Food and Drug Administration's (FDA) own advisers. Hydrocodone combination drugs are some of the most commonly abused prescription drugs nationwide, and your own experts agreed it is time we take the necessary steps to address this deadly epidemic.

Last month, your agency held a Drug Safety and Risk Management (DSaRM) Advisory Committee meeting to publicly discuss the appropriateness of rescheduling hydrocodone combination drugs. The Advisory Committee responded with a resounding 19 to 10 vote in favor of rescheduling hydrocodone combination products. The message could not be more clear. Consequently, we respectfully request that the FDA hasten the rescheduling process and that you provide us with a written response detailing the FDA's next steps and your timeline for rescheduling hydrocodone combination drugs.

Since the hydrocodone combination rescheduling petition was originally filed with the Drug Enforcement Administration (DEA) in 1999, annual recorded toxic exposures to hydrocodone have more than doubled, according to the National Poison Data System. Further, the National Survey on Drug Use and Health has found that lifetime non-medical users of hydrocodone have also more than doubled in that time period -- and currently exceed 24 million Americans. Hydrocodone combination products are currently the top selling controlled substance in the United States by far, with over 139 million prescriptions sold in 2010 alone.

The American people have waited too long for action from this agency. It has been 14 years since the initial petition requesting that the FDA and DEA evaluate the proper scheduling of hydrocodone combination drugs. In those 14 years, there has been a staggering number of hydrocodone related deaths and a drastic increase in non-medical users of these products. The DSaRM Advisory Committee's strong recommendation to the FDA to reschedule these drugs is extremely persuasive and we urge the FDA to take swift action.

Many DSaRM Advisory Committee members and various stakeholders expressed concerns regarding adequate access to pain medication for legitimate pain patients. We share these concerns, and urge you to maintain the specific protections for legitimate pain patients already in place for all Schedule II drugs, including 90-day supplies that must be filled incrementally and emergency refill options. We truly believe that these regulations protect patient access and foster a healthy and supportive patient-doctor relationship.

Again, we respectfully request that the agency reschedule hydrocodone combination drugs without delay. We truly believe that the evidence before you and the DSaRM Advisory Committee's overwhelming recommendation leads to a common sense decision for rescheduling and we look forward to your favorable decision and receiving your response.